12 Jul 2023 • European drug-safety regulators are probing popular weight-loss drug Ozempic after patients reported that the medicine triggered thoughts of suicide and self harm. The European Medicines Agency (EMA) informed on Monday that a safety committee was probing popular weight-loss drugs - including Ozempic, Saxenda and Wegovy - after Iceland’s health regulator flagged three cases of patients on the meds having suicidal and self harm-related thoughts.

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which is conducting the review, will consider whether other treatments in same broader category of medicines, glucagon-like peptide-1 (GLP-1) receptor agonists, also need assessing. But initially, it will assess only the risks of using weight-loss medication that contains either semaglutide or liraglutide.

The manufacturers are working with the EMA and says patient safety is a top priority. A representative said: "GLP-1 receptor agonists have been used to treat type-2 diabetes for more than 15 years and for treatment of obesity for eight years, including products such as semaglutide and liraglutide that have been in the UK market since 2018 and 2009 respectively.

"The safety data collected from large clinical-trial programmes and post-marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and suicidal and self-harming thoughts".

The EMA said it is now evaluating about 150 reports of possible cases of self-injury and suicidal thoughts in patients taking weight loss and diabetes drugs. It’s still unclear if the medicines caused the events or whether they are linked to patients’ underlying conditions or other factors, the statement said.

Source: Forbes | Read full story